Building Clinical Trial Diversity Action Plans for the Future—Now

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Speaker:

Gelise Thomas, Assistant Director, Strategic DEI & Health Disparities, Case Western Reserve University

In this webinar, we will explore recommended elements of a diversity action plan for research as explained in nonbinding recommendations from the Food and Drug Administration (FDA) released in April 2022.

1. Use health disparities knowledge and data to demonstrate validity of clinical trial recruitment methods and goals.
2. Construct operational measures to inform the diversity trial plan.

The omnibus spending bill enacted in December 2022 requires diversity action plans for Phase III clinical trials and marks the first time in history that there is a statutory requirement for diversity in clinical trials. Synthesizing priorities between the FDA and Congress, the diversity action plan should include considerations of race, ethnicity, age, sex, gender, geographic location, and socioeconomic status. Investigators and study teams can look forward to walking through potential content for a clinical trial diversity action plan with a focus on each facet of diversity noted above.